Market Newsdesk

August 17, 2021 7:02 am

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

EMA Validates Bristol Myers Squibb’s Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Applications based on positive results from the Phase 3 CheckMate -648 trial, in which both Opdivo-based combinations demonstrated a significant survival benefit over chemotherapy alone

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the European Medicines Agency (EMA) has validated its Type II Variation Marketing Authorization Applications (MAA) for both Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). Validation of these applications confirm that the submissions are complete and begins the EMA’s centralized review process.

“Outcomes for patients with advanced esophageal squamous cell carcinoma treated with chemotherapy alone remain poor, and there is a clear need for additional options beyond this long-standing standard of care,” said Ian M. Waxman, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “The validation of our applications moves us a step closer to potentially bringing these two Opdivo-based regimens to patients in the EU who may benefit.”

The applications are based on results from the pivotal Phase 3 CheckMate -648 trial, in which both Opdivo-based treatment combinations — Opdivo plus Yervoy and Opdivo plus chemotherapy — demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at the pre-specified interim analysis in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with tumor cell PD-L1 expression ≥1%, as well as in the all-randomized population. Opdivo plus Yervoy is the first dual immunotherapy combination to demonstrate a superior survival benefit versus chemotherapy in this setting. The safety profiles of Opdivo and chemotherapy and of Opdivo plus Yervoy were consistent with the known safety profiles of the individual components.

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program.

Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial.

About CheckMate -648

CheckMate -648 is a randomized Phase 3 study evaluating Opdivo plus Yervoy or Opdivo plus fluorouracil and cisplatin against fluorouracil plus cisplatin alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma. The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) by blinded independent central review (BICR) in patients whose tumors express PD-L1 ≥1% for both Opdivo-based combinations versus chemotherapy. Secondary endpoints of the trial include OS and PFS by BICR in the all-randomized population.

In the Opdivo plus Yervoy arm, patients received treatment with Opdivo 3 mg/kg every 2 weeks and Yervoy 1 mg/kg every 6 weeks up to 24 months or until disease progression or unacceptable toxicity. In the Opdivo plus chemotherapy arm, patients received treatment with Opdivo 240 mg on Day 1 and Day 15, fluorouracil 800 mg/m²/day on Day 1 through Day 5 (for 5 days), and cisplatin 80 mg/m² on Day 1 of four-week cycle. Patients received Opdivo for up to 24 months or until disease progression or unacceptable toxicity, and chemotherapy until disease progression or unacceptable toxicity.

About Esophageal Cancer

Esophageal cancer is the eighth most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region with the highest rate of esophageal squamous cell carcinoma occurring in Asia (~95%), Europe (~65%) and North America (35%).

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

INDICATIONS

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO^®(nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO^® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO^® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO^® (nivolumab), in combination with YERVOY^® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO^® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO^® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

OPDIVO^® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).

In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).

In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).

In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).

In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).

Immune-Mediated Nephritis with Renal Dysfunction

OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).

Immune-Mediated Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/ exfoliative rashes.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).

In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.

Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥ 2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation.

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%), dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%).

Please see US Full Prescribing Information for OPDIVO and YERVOY.

Clinical Trials and Patient Populations

Checkmate 037–previously treated metastatic melanoma; Checkmate 066–previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 227–previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 025–previously treated renal cell carcinoma; Checkmate 205/039–classical Hodgkin lymphoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 275–urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 238–adjuvant treatment of melanoma; Attraction-3–esophageal squamous cell carcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 649–previously untreated advanced or metastatic gastric or gastroesophageal junction or esophageal adenocarcinoma.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that the combination treatments not receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatments for such indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20210817005199/en/

Bristol Myers Squibb

Media:

[email protected]

Investors:

Tim Power

609-252-7509

[email protected]

Nina Goworek

908-673-9711

[email protected]

KEYWORDS: Europe United States North America New Jersey

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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August 17, 2021 6:58 am

Brookfield Asset Management Announces Renewal of Normal Course Issuer Bid for Preferred Shares

BROOKFIELD, NEWS, Aug. 17, 2021 (GLOBE NEWSWIRE) — Brookfield Asset Management Inc. (NYSE: BAM) (TSX: BAM.A) (“Brookfield” or “the company”) today announced it has received approval from the Toronto Stock Exchange (“TSX”) for the renewal of its normal course issuer bid to purchase up to 10% of the public float of each series of the company’s outstanding Class A Preference Shares that are listed on the TSX (the “Preferred Shares”). Purchases under the bid will be made through the facilities of the TSX and/or alternative Canadian trading systems. The period of the normal course issuer bid will extend from August 20, 2021 to August 19, 2022, or an earlier date should Brookfield complete its purchases. Brookfield will pay the market price at the time of acquisition for any Preferred Shares purchased. All Preferred Shares acquired by Brookfield under this bid will be cancelled.

Under the normal course issuer bid, Brookfield is authorized to repurchase each respective series of the Preferred Shares as follows:

Series	Ticker	Issued and outstanding shares¹	Public float¹	Average daily trading volume²	Maximum number of shares subject to purchase³
Series	Ticker	Issued and outstanding shares¹	Public float¹	Average daily trading volume²	Total	Daily
Series 2	BAM.PR.B	10,457,685	10,220,175	13,979	1,022,018	3,449
Series 4	BAM.PR.C	3,995,910	3,983,910	8,130	398,391	2,032
Series 8	BAM.PR.E	2,476,185	2,475,185	1,180	247,519	1,000
Series 9	BAM.PR.G	5,515,981	2,022,881	888	202,288	1,000
Series 13	BAM.PR.K	9,640,096	8,792,596	21,350	879,260	5,337
Series 17	BAM.PR.M	7,840,204	7,840,204	7,869	784,020	1,967
Series 18	BAM.PR.N	7,866,749	7,681,088	4,619	768,109	1,154
Series 24	BAM.PR.R	10,808,027	10,808,027	13,305	1,080,803	3,326
Series 26	BAM.PR.T	9,770,928	9,770,928	11,599	977,093	2,899
Series 28	BAM.PR.X	9,233,927	9,233,927	17,932	923,393	4,483
Series 30	BAM.PR.Z	9,787,090	9,787,090	7,141	978,709	1,785
Series 32	BAM.PF.A	11,750,299	11,750,299	11,414	1,175,030	2,853
Series 34	BAM.PF.B	9,876,735	9,876,735	6,296	987,674	1,574
Series 36	BAM.PF.C	7,842,909	7,842,909	7,400	784,291	1,850
Series 37	BAM.PF.D	7,830,091	7,830,091	9,027	783,009	2,256
Series 38	BAM.PF.E	7,906,132	7,906,132	6,219	790,613	1,554
Series 40	BAM.PF.F	11,841,025	11,841,025	6,799	1,184,103	1,699
Series 42	BAM.PF.G	11,887,500	11,887,500	9,238	1,188,750	2,309
Series 44	BAM.PF.H	9,831,929	9,831,929	6,354	983,193	1,588
Series 46	BAM.PF.I	11,740,797	11,740,797	9,966	1,174,080	2,491
Series 48	BAM.PF.J	11,885,972	11,885,972	12,419	1,188,597	3,104

________________________________

Calculated as
at
August
5
, 2021
.
Calculated for the six months
ended
July 31,
2021
.
In accordance with TSX rules, any daily repurchases with respect to: (i) the
Series 8
and
Series 9
Preferred Shares
will
be limited to 1,000 shares of the respective series and (ii) each of the other series of Preferred Shares (excluding the
Series 8
and
Series

9
Preferred Shares)
will
be limited to 25% of the average daily trading volume on the TSX of the respective series.

As of August 13, 2021, under its current normal course issuer bid that commenced on August 20, 2020 and will expire on August 19, 2021, and which was approved by the TSX, Brookfield has not made any purchases of the Preferred Shares.

Brookfield is renewing its normal course issuer bid because it believes that, from time to time, the Preferred Shares may trade in price ranges that do not fully reflect their value. Brookfield believes that, in such circumstances, acquiring the Preferred Shares represents an attractive and desirable use of its available funds.

Brookfield will enter into an automatic share purchase plan on or about the week of September 20, 2021 in relation to the normal course issuer bid. The automatic share purchase plan will allow for the purchase of Preferred Shares, subject to certain trading parameters, at times when Brookfield ordinarily would not be active in the market due to its own internal trading black-out period, insider trading rules or otherwise. Outside of these periods, the Preferred Shares will be repurchased in accordance with management’s discretion and in compliance with applicable law.

Brookfield Asset Management Inc.
Brookfield Asset Management is a leading global alternative asset manager with over US$625 billion of assets under management across real estate, infrastructure, renewable power, private equity and credit. Brookfield owns and operates long-life assets and businesses, many of which form the backbone of the global economy. Utilizing its global reach, access to large-scale capital and operational expertise, Brookfield offers a range of alternative investment products to investors around the world—including public and private pension plans, endowments and foundations, sovereign wealth funds, financial institutions, insurance companies and private wealth investors. Brookfield Asset Management is listed on the New York and Toronto stock exchanges under the symbols BAM and BAM.A, respectively.

For more information, please visit our website at www.brookfield.com or contact:

Kerrie McHugh
Communications
Tel: (212) 618-3464
Email: [email protected]

Linda Northwood
Investor Relations
Tel: (416) 359-8647
Email: [email protected]

Forward-Looking Statements

Note: This news release contains “forward-looking information” within the meaning of Canadian provincial securities laws and “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 and in any applicable Canadian securities regulations. The word “believe,” conditional verbs such as “will,” “may” and derivations thereof and other expressions that are predictions of or indicate future events, trends or prospects and which do not relate to historical matters identify forward-looking statements.

Forward-looking information in this news release includes statements with regards to potential future purchases by Brookfield of its Class A Preference Shares pursuant to the company’s normal course issuer bid and automatic share purchase plan. Although Brookfield believes that the anticipated future results or achievements expressed or implied by the forward-looking statements and information is based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements and information because they involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company to differ materially from anticipated future results, performance or achievement expressed or implied by such forward-looking statements and information.

Factors that could cause actual results to differ materially from those contemplated or implied by forward-looking statements include: general economic conditions; interest rate changes; availability of equity and debt financing; the performance of the Class A Preference Shares or the stock exchanges generally; and other risks and factors described from time to time in the documents filed by the company with the securities regulators in Canada and the United States including in Management’s Discussion and Analysis under the heading “Business Environment and Risks”. The company undertakes no obligation to publicly update or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise.

August 17, 2021 6:58 am

Eneti Inc. Announces Financial Results for the Second Quarter of 2021 and Declares a Quarterly Cash Dividend

MONACO, Aug. 17, 2021 (GLOBE NEWSWIRE) — Eneti Inc. (NYSE: NETI) (“Eneti” or the “Company”), today reported its results for the three months ended June 30, 2021.

The Company also announced that on August 16, 2021 its Board of Directors declared a quarterly cash dividend of $0.01 per share on the Company’s common shares.

Results for the Three and Six Months Ended June 30, 2021 and 2020

For the second quarter of 2021, the Company’s GAAP net income was $13.0 million, or $1.19 per diluted share, including:
- a gain on vessels sold of approximately $6.5 million, or $0.59 per diluted share, which is primarily the result of an increase in the fair value of common shares of Star Bulk Carriers Corp. (“Star Bulk”) (NASDAQ: SBLK) and Eagle Bulk Shipping Inc. (“Eagle”) (NASDAQ: EGLE) received as a portion of the compensation for the purchase of certain of our vessels;
- the write-off of $3.3 million, or $0.30 per diluted share, of deferred financing costs on repaid credit facilities related to certain vessels that have been sold; and
- a gain of approximately $13.0 million and cash dividend income of $0.2 million, or $1.21 per diluted share, from the Company’s equity investment in Scorpio Tankers Inc. and the sale of the Eagle and Star Bulk shares received as part of the consideration for the sales of vessels to these counterparties.

For the second quarter of 2020, the Company’s GAAP net loss was $45.1 million, or $5.73 per diluted share. These results include a non-cash loss of approximately $13.9 million and cash dividend income of $0.2 million, or $1.74 per diluted share, from the Company’s equity investment in Scorpio Tankers Inc., and a write-off of approximately $0.4 million, or $0.05 per diluted share, of deferred financing costs related to debt repayments on vessels sold in the second quarter of 2020.
Total vessel revenues for the second quarter of 2021 were $37.7 million, compared to $26.2 million for the same period in 2020.
Earnings before interest, taxes, depreciation and amortization (“EBITDA”) for the second quarter of 2021 was $19.7 million and EBITDA for the second quarter of 2020 was a loss of $20.6 million (see Non-GAAP Financial Measures below).
For the second quarter of 2021, the Company’s adjusted net income was $9.9 million, or $0.90 adjusted per diluted share, which excludes the impact of the gain of approximately $6.5 million related to the Company’s previously announced plan to exit the dry bulk industry due to an increase in the fair value of the assets to be received in exchange for certain vessels and changes in related selling costs as described above and the write-off of $3.3 million of deferred financing costs on repaid credit facilities related to certain vessels that have been sold.
For the second quarter of 2020, the Company’s adjusted net loss was $44.7 million, or $5.68 adjusted per diluted share, which excludes the write-off of approximately $0.4 million of deferred financing costs related to debt repayments on to vessels sold in the second quarter of 2020.
Adjusted EBITDA for the second quarter of 2021 was $13.2 million compared to a $20.6 million loss in the prior year period (see Non-GAAP Financial Measures below).
For the first half of 2021, the Company’s GAAP net income was $54.9 million, or $5.03 per diluted share, including:
- a gain on vessels sold of approximately $22.0 million, or $2.01 per diluted share, which is primarily the result of an increase in the fair value of common shares of Star Bulk (NASDAQ: SBLK) and Eagle (NASDAQ: EGLE) received as a portion of the consideration for the sale of certain of our vessels to Star Bulk and Eagle;
- the write-off of $7.0 million, or $0.64 per diluted share, of deferred financing costs on repaid credit facilities related to certain vessels that have been sold; and
- a gain of approximately $28.8 million and cash dividend income of $0.4 million, or $2.68 per diluted share, from the Company’s equity investment in Scorpio Tankers Inc. and the sale of the Eagle and Star Bulk shares received as a portion of the consideration for the vessel sales to these counterparties.
For the first half of 2020, the Company’s GAAP net loss was $169.8 million, or $23.01 per diluted share, including a loss of approximately $103.0 million and cash dividend income of $0.7 million, or $13.87 per diluted share, from the Company’s equity investment in Scorpio Tankers Inc.; a write-down of assets held for sale of approximately $17.0 million, or $2.31 per diluted share, related to the classification of three vessels as held for sale in the first quarter of 2020 (the sales of all three vessels were completed in the second quarter of 2020); and a write-off of approximately $0.4 million, or $0.05 per diluted share, of deferred financing costs on the credit facilities related to those three vessels.
Total vessel revenues for the first half of 2021 were $97.5 million, compared to $67.0 million for the same period in 2020. EBITDA for the first half of 2021 was $71.7 million and EBITDA for the first half of 2020 was a loss of $120.7 million (see Non-GAAP Financial Measures below).
For the first half of 2021, the Company’s adjusted net income was $39.9 million, or $3.66 adjusted per diluted share, which excludes the impact of a gain subsequent to an increase in fair value less costs to sell related to the assets held for sale of $22.0 million and the write-off of deferred financing costs on the related credit facilities of $7.0 million. Adjusted EBITDA for the first half of 2021 was $49.7 million (see Non-GAAP Financial Measures below).
For the first half of 2020, the Company’s adjusted net loss was $152.4 million, or $20.65 adjusted per diluted share, which excludes the impact of the write-down of assets held for sale of $17.0 million and the write-off of deferred financing costs on the related credit facilities of $0.4 million. Adjusted EBITDA for the first half of 2020 was a loss of $103.7 million (see Non-GAAP Financial Measures below).

Liquidity

As of August 13, 2021, the Company had approximately $41.7 million in cash and cash equivalents. The Company also continues to hold approximately 2.16 million common shares of Scorpio Tankers Inc. (NYSE: STNG).

Seajacks Transaction

On August 12, 2021, the Company completed a previously announced transaction whereby one of its wholly-owned direct subsidiaries acquired from Marubeni Corporation, INCJ Ltd and Mitsui OSK Lines Ltd. (together, the “Sellers”) 100% of Atlantis Investorco Limited, the parent of Seajacks International Limited (“Seajacks”), for consideration of approximately 8.13 million shares, $302 million of assumed net debt, $71 million of newly-issued redeemable notes, and $12 million of cash. Upon completion, 7,000,000 common shares and 700,000 preferred shares were issued to the Sellers with the remainder expected to be issued prior to the end of 2021.

Seajacks (www.seajacks.com) was founded in 2006 and is based in Great Yarmouth, UK. It is one of the largest owners of purpose-built self-propelled WTIVs in the world and has a track record of installing wind turbines and foundations dating to 2009. Seajacks’ flagship, NG14000X design “Seajacks Scylla”, was delivered from Samsung Heavy Industries in 2015, and it is currently employed in Asia. Seajacks also owns and operates the NG5500C design “Seajacks Zaratan” which is currently operating in the Japanese market under the Japanese flag, as well as three NG2500X specification WTIVs.

Dry Bulk Exit

During July 2021, the Company completed its exit from the business of dry bulk commodity transportation. The following table summarizes when the Company delivered the vessels to their respective buyers.

	Ultramax Vessels		Kamsarmax Vessels		Total Vessels
Quarter	# of Vessels	Sales Price ($000’s)	# of Vessels	Sales Price ($000’s)	# of Vessels	Sales Price ($000’s)
Unsold Vessels at September 30, 2020	33		16		49
Q4 2020	5	$88,460	3	$54,865	8	$143,325
Q1 2021	11	$187,333	7	$123,127	18	$310,460	₍₁₎₍₂₎
Q2 2021	17	$294,576	5	$98,566	22	$393,142	_(3)(4)(5)
Q3 2021: July 1 – July 19	0	$0	1	$20,339	1	$20,339	₍₆₎
Total Vessels Sold	33	$570,369	16	$296,897	49	$867,266
Unsold Vessels at August 10, 2021	0		0		0

⁽¹⁾ Includes approximately $89.3 million of debt assumed or reimbursed to the Company by buyer
⁽²⁾ Excludes approximately 2.6 million shares of Star Bulk common stock
⁽³⁾ Includes approximately $78.3 million of debt assumed by buyers
⁽⁴⁾ Excludes approximately 0.4 million shares of Star Bulk common stock
⁽⁵⁾ Excludes a warrant for 212,315 shares of Eagle common stock
⁽⁶⁾ Includes approximately $18.3 million of debt assumed by buyer

Sale of Five Vessels

During the second quarter of 2021, the Company entered into binding agreements with counterparties in Japan to transfer the existing lease finance arrangements of the SBI Tango, SBI Echo, and SBI Hermes, Ultramax bulk carriers built in 2015, 2015, and 2016 respectively, and SBI Rumba and SBI Samba, Kamsarmax bulk carriers built in 2015, to affiliates of Scorpio Holdings Limited (“SHL”) for consideration of $16.0 million. This transaction was approved by the Company’s independent directors in January 2021. As of July 2021, the Company transferred all five vessels and the related debt to SHL.

Star Bulk and Eagle Common Shares

During May 2021, the Company sold approximately 0.4 million common shares of Star Bulk, which it received as partial compensation for the SBI Pegasus for net proceeds of $7.7 million. Star Bulk also assumed debt of $12.7 million and the Company was reimbursed for the February 2021 debt payment that was made in advance.

During June 2021, the Company sold approximately 0.2 million common shares of Eagle, which it received as partial consideration for the SBI Virgo for net proceeds of $10.2 million. The Company also received cash proceeds of $15.0 million as part of the purchase price.

Debt Overview

The Company’s outstanding debt balances, gross of unamortized deferred financing costs as of June 30, 2021 and August 13, 2021, are as follows (dollars in thousands):

	As of June 30, 2021		As of August 13, 2021
Credit Facility	Amount Outstanding
$21.4 Million Lease Financing – SBI Samba	$	18,212	—
$60.0 Million ING Loan Facility	—		40,000
$87.7 Million Subordinated Debt	—		87,650
$70.7 Million Redeemable Notes	—		70,686
Total	$	18,212	$	198,336

As part of the Seajacks transaction, the Company:

Drewdown $40.0 million on a $60.0 million a senior secured non-amortizing revolving credit facility from ING Bank N.V. The credit facility, which includes sub-limits for performance bonds, and is subject to other conditions for full availability, has a final maturity of August 2022 and bears interest at LIBOR plus a margin of 2.45% per annum.
Assumed $87.7 million of subordinated, non-amortizing debt due in September 2022 and owed to financial institutions with guarantees provided by the Sellers, which bears interest at 1.0% until November 30, 2021, 5.5% from December 1, 2021 and 8.0% from January 1, 2022.
Issued subordinated redeemable notes totaling $70.7 million, with a final maturity of March 31, 2023 and bears interest at 5.5% until December 31, 2021 and 8.0% afterwards.
Repaid the existing secured debt of approximately $267.5 million.

Quarterly Cash Dividend

In the second quarter of 2021, the Company’s Board of Directors declared and the Company paid a quarterly cash dividend of $0.05 per share totaling approximately $0.6 million.

On August 16, 2021, the Company’s Board of Directors declared a quarterly cash dividend of $0.01 per share, payable on or about September 15, 2021, to all shareholders of record as of August 31, 2021. As of August 17, 2021, 18,233,604 common shares and 700,000 preferred shares were outstanding.

Share Repurchase Program

As of August 17, 2021, the Company had $31.9 million remaining under the authorized share repurchase program. The Company did not repurchase any securities during the three months ended June 30, 2021.

COVID-19

Since the beginning of the calendar year 2020, the ongoing outbreak of the novel coronavirus (COVID-19) that originated in China in December 2019 and that has spread to most developed nations of the world has resulted in numerous actions taken by governments and governmental agencies in an attempt to mitigate the spread of the virus. These measures have resulted in a significant reduction in global economic activity and extreme volatility in the global financial and commodities markets. During the first quarter of 2021, the dry bulk charter market saw a significant recovery, however future charter rates remain highly dependent on the duration and continuing impact of the COVID-19 pandemic, as evidenced by the recent resurgence of cases in India and other parts of the world. When these measures and the resulting economic impact will end and what the long-term impact of such measures on the global economy will be are not known at this time. As a result, the extent to which COVID-19 will impact the Company’s results of operations and financial condition, including its planned transition towards marine-based renewable energy, will depend on future developments, which are highly uncertain and cannot be predicted.

Eneti Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

(Amounts in thousands, except per share data)

	Unaudited
	Three Months Ended June 30,						Six Months Ended June 30,
	2021			2020			2021			2020
Revenue:
Vessel revenue	$	37,651		$	26,166		$	97,480		$	66,990
Operating expenses:
Voyage expenses	8,502			1,460			14,582			2,820
Vessel operating costs	8,240			22,251			23,850			46,935
Charterhire expense	17,366			4,476			29,346			9,174
Vessel depreciation	—			12,680			—			25,023
General and administrative expenses	5,134			6,777			12,719			13,305
(Gain) loss / write-down on assets sold or held for sale	(6,452		)	—			(21,984		)	17,009
Total operating expenses	32,790			47,644			58,513			114,266
Operating income (loss)	4,861			(21,478		)	38,967			(47,276		)
Other income (expense):
Interest income	31			49			39			172
Income (loss) from equity investments	13,246			(13,693		)	29,217			(102,324		)
Foreign exchange (loss) income	(68		)	(76		)	3			(130		)
Financial expense, net	(5,057		)	(9,853		)	(13,350		)	(20,196		)
Total other income (expense)	8,152			(23,573		)	15,909			(122,478		)
Net income (loss)	$	13,013		$	(45,051	)	$	54,876		$	(169,754	)

Earnings (loss) per share:
Basic	$	1.22		$	(5.73	)	$	5.16		$	(23.01	)
Diluted	$	1.19		$	(5.73	)	$	5.03		$	(23.01	)

Basic weighted average number of common shares outstanding	10,626			7,868			10,628			7,379
Diluted weighted average number of common shares outstanding	10,921			7,868			10,907			7,379

Eneti Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(Dollars in thousands)

	Unaudited
	June 30, 2021			December 31, 2020
Assets
Current assets
Cash and cash equivalents	$	270,787		$	84,002
Accounts receivable	12,473			21,086
Prepaid expenses and other current assets	1,912			16,515
Total current assets	285,172			121,603
Non-current assets
Assets held for sale	17,008			708,097
Equity investments	47,521			24,116
Deferred financing costs, net	—			1,143
Other assets	10,750			13,236
Total non-current assets	75,279			746,592
Total assets	$	360,451		$	868,195

Liabilities and shareholders’ equity
Current liabilities
Bank loans, net	$	—		$	13,226
Capital lease obligations	1,532			32,677
Accounts payable and accrued expenses	13,945			41,113
Total current liabilities	15,477			87,016
Non-current liabilities
Bank loans, net	—			157,511
Capital lease obligations	16,506			351,070
Total non-current liabilities	16,506			508,581
Total liabilities	31,983			595,597
Shareholders’ equity
Preferred shares, $0.01 par value per share; 50,000,000 shares authorized; no shares issued or outstanding	—			—
Common shares, $0.01 par value per share; authorized 31,875,000 shares as of June 30, 2021 and December 31, 2020; outstanding 11,233,604 shares as of June 30, 2021 and 11,310,073 as of December 31, 2020	839			859
Paid-in capital	1,731,718			1,803,431
Common shares held in treasury, at cost; 35,869 shares and 1,934,092 shares at June 30, 2021 and December 31, 2020, respectively	(717		)	(73,444		)
Accumulated deficit	(1,403,372		)	(1,458,248		)
Total shareholders’ equity	328,468			272,598
Total liabilities and shareholders’ equity	$	360,451		$	868,195

Eneti Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows (unaudited)

(Amounts in thousands)

	Six Months ended June 30,
	2021			2020
Operating activities
Net income (loss)	$	54,876		$	(169,754	)
Adjustment to reconcile net income (loss) to net cash provided by
operating activities:
Restricted share amortization	3,526			4,019
Vessel depreciation	—			25,023
Amortization of deferred financing costs	652			2,022
Write-off of deferred financing costs	7,028			366
(Gain) loss / write-down on assets held for sale	(19,598		)	15,420
Net unrealized (gains) losses on investments	(28,786		)	102,980
Dividend income on equity investment	(431		)	(656		)
Drydocking expenditure	(3,443		)	(10,775		)
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable	8,614			(1,269		)
Decrease in prepaid expenses and other assets	24,610			12,774
Decrease in accounts payable and accrued expenses	(27,163		)	(15,251		)
Net cash provided by (used in) operating activities	19,885			(35,101		)
Investing activities
Sale of equity investment	63,377			42,711
Dividend income on equity investment	431			656
Proceeds from sale of assets held for sale	482,039			52,518
Scrubber payments	(9,311		)	(37,805		)
Net cash provided by (used in) investing activities	536,536			58,080
Financing activities
Proceeds from issuance of common stock	—			82,254
Proceeds from issuance of long-term debt	—			110,179
Repayments of long-term debt	(367,105		)	(187,624		)
Common shares repurchased	(1,407		)	—
Dividends paid	(1,124		)	(2,011		)
Net cash (used in) provided by financing activities	(369,636		)	2,798
Increase (decrease) in cash and cash equivalents	186,785			25,777
Cash and cash equivalents, beginning of period	84,002			42,530
Cash and cash equivalents, end of period	$	270,787		$	68,307

Conference Call on Results:

A conference call to discuss the Company’s results will be held at 10:00 AM Eastern Daylight Time / 4:00 PM Central European Summer Time on August 17, 2021. Those wishing to listen to the call should dial 1 (866) 219-5268 (U.S.) or 1 (703) 736-7424 (International) at least 10 minutes prior to the start of the call to ensure connection. The conference participant passcode is 9674972. The information provided on the teleconference is only accurate at the time of the conference call, and the Company will take no responsibility for providing updated information.

There will also be a simultaneous live webcast over the internet, through the Eneti Inc. website www.eneti-inc.com. Participants to the live webcast should register on the website approximately 10 minutes prior to the start of the webcast.

Webcast URL: https://edge.media-server.com/mmc/p/qbrxqqmw

About Eneti Inc.

Eneti Inc. owns and operates five wind turbine installation vessels (“WTIV”s) serving the offshore wind industry and has an additional high specification WTIV under construction. Additional information about the Company is available on the Company’s website www.eneti-inc.com, which is not a part of this press release.

Non-GAAP Financial Measures

To supplement the Company’s financial information presented in accordance with accounting principles generally accepted in the U.S. (“GAAP”) management uses certain “non-GAAP financial measures” as such term is defined in Regulation G promulgated by the U.S. Securities and Exchange Commission (the “SEC”). Generally, a non-GAAP financial measure is a numerical measure of a company’s operating performance, financial position or cash flows that excludes or includes amounts that are included in, or excluded from, the most directly comparable measure calculated and presented in accordance with GAAP. Management believes the presentation of these measures provides investors with greater transparency and supplemental data relating to the Company’s financial condition and results of operations, and therefore a more complete understanding of factors affecting its business than GAAP measures alone. In addition, management believes the presentation of these matters is useful to investors for period-to-period comparison of results as the items may reflect certain unique and/or non-operating items such as asset sales, write-offs, contract termination costs or items outside of management’s control.

Earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income (loss) and related per share amounts, as well as adjusted EBITDA are non-GAAP financial measures that the Company believes provide investors with a means of evaluating and understanding how the Company’s management evaluates the Company’s operating performance. These non-GAAP financial measures should not be considered in isolation from, as substitutes for, nor superior to financial measures prepared in accordance with GAAP. Please see below for reconciliations of EBITDA, adjusted net income (loss) and related per share amounts, and adjusted EBITDA.

EBITDA (unaudited)

	Three Months Ended June 30,				Six Months ended June 30,
In thousands	2021		2020		2021		2020
Net income (loss)	$	13,013	(45,051	)	$	54,876	$	(169,754	)
Add Back:
Net interest expense	1,574		8,430		5,630		17,637
Depreciation and amortization ⁽¹⁾	5,087		15,992		11,206		31,430
EBITDA	$	19,674	(20,629	)	$	71,712	$	(120,687	)

⁽¹⁾ Includes depreciation, amortization of deferred financing costs and restricted share amortization.

Adjusted net income (loss) (unaudited)

	Three Months Ended June 30,
In thousands, except per share data	2021						2020
	Amount			Per share			Amount			Per share
Net income (loss)	$	13,013		$	1.19		$	(45,051	)	$	(5.73	)
Adjustments:
(Gain) loss / write-down on assets	(6,452		)	(0.59		)	—			—
Write-off of deferred financing cost	3,315			0.30			366			0.05
Total adjustments	$	(3,137	)	$	(0.29	)	$	366		$	0.05
Adjusted net income (loss)	$	9,876		$	0.90		$	(44,685	)	$	(5.68	)

	Six Months Ended June 30,
In thousands, except per share data	2021						2020
	Amount			Per share			Amount			Per share
Net income (loss)	$	54,876		$	5.03		$	(169,754	)	$	(23.01	)
Adjustments:
(Gain) loss / write-down on assets	(21,984		)	(2.01		)	17,009			2.31
Write-off of deferred financing cost	7,028			0.64			366			0.05
Total adjustments	$	(14,956	)	$	(1.37	)	$	17,375		$	2.36
Adjusted net income (loss)	$	39,920		$	3.66		$	(152,379	)	$	(20.65	)

Adjusted EBITDA (unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
In thousands	2021			2020			2021			2020
Net income (loss)	$	13,013		(45,051		)	$	54,876		$	(169,754	)
Impact of adjustments	(3,137		)	366			(14,956		)	17,375
Adjusted net (loss) income	9,876			(44,685		)	39,920			(152,379		)
Add Back:
Net interest expense	1,574			8,430			5,630			17,637
Depreciation and amortization ⁽¹⁾	1,772			15,626			4,178			31,064
Adjusted EBITDA	$	13,222		$	(20,629	)	$	49,728		$	(103,678	)

⁽¹⁾ Includes depreciation, amortization of deferred financing costs and restricted share amortization.

Forward-Looking Statements

Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts. The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements. We undertake no obligation, and specifically decline any obligation, except as required by law, to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections.

In addition to these important factors, other important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the failure of counterparties to fully perform their contracts with us, the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and asset values, changes in demand for Wind Turbine Installation Vessel (“WTIV”) capacity, the length and severity of the ongoing novel coronavirus (COVID-19) outbreak, including its effects on demand for WTIVs and the installation of offshore windfarms thereof, changes in our operating expenses, including fuel costs, drydocking and insurance costs, the market for our WTIVs, availability of financing and refinancing, counterparty performance, ability to obtain financing and the availability of capital resources (including for capital expenditures) and comply with covenants in such financing arrangements, planned capital expenditures, our ability to successfully identify, consummate, integrate and realize the expected benefits from acquisitions and changes to our business strategy, fluctuations in the value of our investments, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption due to accidents or political events, vessel breakdowns and instances of off-hires and other factors.

Please see our filings with the Securities and Exchange Commission for a more complete discussion of these and other risks and uncertainties.

Contact:

Eneti Inc.
+377-9798-5715 (Monaco)
+1-646-432-1675 (New York)

August 17, 2021 6:58 am

Sonic Automotive Continues to Grow Its EchoPark Nationwide Distribution Network & Digital Expansion with Opening in Las Vegas, Nevada

Sonic Automotive Continues to Grow Its EchoPark Nationwide Distribution Network & Digital Expansion with Opening in Las Vegas, Nevada

30th Location Nationwide Brings the EchoPark Brand to Over Two Million Additional Consumers

LAS VEGAS–(BUSINESS WIRE)–Sonic Automotive, Inc. (“Sonic” or the “Company”) (NYSE:SAH), a Fortune 500 Company and one of the nation’s largest automotive retailers, today announced the continued expansion of the EchoPark Automotive brand with the opening of its newest retail hub in the Las Vegas market, its first in the state of Nevada.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210817005068/en/

EchoPark Las Vegas – 1100 West Warm Springs Road, Henderson, Nevada (Photo: Business Wire)

“EchoPark Las Vegas is an important part of our growing omnichannel solution for consumers, and offers guests who visit in-store or shop online at EchoPark.com an entirely new way to buy cars,” said David Smith, Chief Executive Officer of Sonic Automotive and EchoPark Automotive. “Our rapidly growing distribution network brings an exciting, seamless guest experience to another key market, while offering a new population of car buyers savings of up to $3,000 versus the competition.”

EchoPark guests are able to shop in person or take delivery of their purchase at our new Las Vegas location after conveniently shopping online at EchoPark.com and choosing from over 10,000 high quality, one- to four-year-old pre-owned vehicles under original factory warranty, with clean CarFax reports. Our easy, transparent online purchase experience includes below-market, no-haggle pricing (including taxes and fees), a firm trade-in vehicle offer, competitive financing solutions and the ability to choose from a selection of quality vehicle protection plans. After scheduling a pickup appointment at an EchoPark delivery center or retail sales center, guests will be greeted by an EchoPark Experience Guide to help answer any questions and finalize all vehicle purchase details before quickly getting them on their way home with their new purchase. With over 15,000 five-star reviews to date, the EchoPark experience is clearly resonating with guests.

“The opening of EchoPark Las Vegas is a key component of the Company’s ongoing growth strategy, as we continue to execute our accelerated expansion plan to meet the strong demand for pre-owned vehicles across the nation,” said Jeff Dyke, President of Sonic and EchoPark Automotive.

Following its 2014 launch, EchoPark Automotive has rapidly become one of the pre-owned automotive retail industry’s most prominent success stories. The Company continues to expand its EchoPark footprint into new markets and anticipates 90 percent population coverage by 2025, enabling its interim goal of retailing 575,000 vehicles and generating $14 billion in annual EchoPark revenues by 2025, while driving toward a two million vehicle annual sales opportunity at maturity.

Find Our Newest Locations

EchoPark Las Vegas is located at 1100 West Warm Springs Road, Henderson, Nevada and will be open Monday to Saturday from 9am to 9pm. The store can be reached at (725) 240-9003, or online at www.echopark.com/dealerships/las-vegas.

The 20,500-square-foot EchoPark Las Vegas store will employ approximately 40 team members when fully staffed.

About EchoPark Automotive

EchoPark Automotive is a rapidly growing operating segment within the Company that specializes in pre-owned vehicle sales, utilizing technology to provide a unique, guest-centric buying experience and deliver superior value to customers. More information about EchoPark Automotive can be found at www.echopark.com.

About Sonic Automotive

Sonic Automotive, Inc., a Fortune 500 company based in Charlotte, North Carolina, is one of the nation’s largest automotive retailers. Sonic can be reached on the web atwww.sonicautomotive.com.

Forward-Looking Statements

Included herein are forward-looking statements, including statements regarding anticipated future revenue levels, future profitability, pre-owned vehicle sales projections, the opening of additional EchoPark markets, and future population coverage. There are many factors that affect management’s views about future events and trends of the Company’s business. These factors involve risks and uncertainties that could cause actual results or trends to differ materially from management’s views, including, without limitation, economic conditions in the markets in which we operate, new and used vehicle industry sales volume, anticipated future growth in our EchoPark Segment, the success of our operational strategies, the rate and timing of overall economic expansion or contraction, the effect of the COVID-19 pandemic and related government-imposed restrictions on operations, and the risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and other reports and information filed with the Securities and Exchange Commission (the “SEC”). The Company does not undertake any obligation to update forward-looking information, except as required under federal securities laws and the rules and regulations of the SEC.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210817005068/en/

Company Contacts

Investor Inquiries:

Heath Byrd, Executive Vice President and Chief Financial Officer 704-566-2400

Danny Wieland, Vice President, Investor Relations 704-927-3462

[email protected]

Press Inquiries:

Joshua Greenwald / Danielle DeVoren

646-379-7971 / 212-896-1272

[email protected] / [email protected]

KEYWORDS: United States North America Nevada

INDUSTRY KEYWORDS: Online Retail Retail Automotive General Automotive Other Automotive Specialty

MEDIA:

Logo

Photo

EchoPark Las Vegas – 1100 West Warm Springs Road, Henderson, Nevada (Photo: Business Wire)

Posted on August 17, 2021 6:53 am
Genesco Inc. To Report Second Quarter Fiscal 2022 Results And Hold Conference Call On September 2, 2021

PR Newswire

NASHVILLE, Tenn., Aug. 17, 2021 /PRNewswire/ — Genesco Inc. (NYSE: GCO) today announced that the Company will report results for the second quarter fiscal 2022 on September 2, 2021, before the market opens, and hold its quarterly earnings conference call at 7:30 a.m. (central) the same day.

A live audio webcast of the conference call will be available at http://genesco.gcs-web.com/financial-information/quarterly-results

An audio archive of the call will be available at http://genesco.gcs-web.com/financial-information/quarterly-results for up to one year

In addition, a summary of the second quarter results will be available on the Genesco website on September 2, 2021, at http://genesco.gcs-web.com/financial-information/quarterly-results

About Genesco Inc.
Genesco Inc., a Nashville-based specialty retailer and branded company, sells footwear and accessories in more than 1,455 retail stores throughout the U.S., Canada, the United Kingdom and the Republic of Ireland, principally under the names Journeys, Journeys Kidz, Little Burgundy, Schuh, Schuh Kids, Johnston & Murphy, and on internet websites www.journeys.com, www.journeyskidz.com, www.journeys.ca, www.littleburgundyshoes.com, www.schuh.co.uk, www.johnstonmurphy.com, www.johnstonmurphy.ca, www.nashvilleshoewarehouse.com, and www.dockersshoes.com. In addition, Genesco sells footwear at wholesale under its Johnston & Murphy brand, the licensed Levi’s brand, the licensed Dockers brand, the licensed Bass brand, and other brands. For more information on Genesco and its operating divisions, please visit www.genesco.com.

View original content:https://www.prnewswire.com/news-releases/genesco-inc-to-report-second-quarter-fiscal-2022-results-and-hold-conference-call-on-september-2-2021-301356379.html

SOURCE Genesco Inc.

Posted on August 17, 2021 6:48 am
Quest Diagnostics Elects Tracey C. Doi to Board of Directors

PR Newswire

SECAUCUS, N.J., Aug. 17, 2021 /PRNewswire/ — Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, today announced that its Board of Directors has elected Ms. Tracey C. Doi to serve as a director. Including Ms. Doi, the company’s Board has 10 members.

Ms. Doi is the Chief Financial Officer of Toyota Motor North America, where she is responsible for accounting, finance, tax and enterprise strategy. As an executive member of the North America Management Committee, Ms. Doi sets strategy and mid-to-long-term business plans, and drives initiatives to increase competitiveness in manufacturing, sales, marketing, digital technology and supply chain. She is a change agent skilled in strategic planning, business analytics, enterprise systems, risk and corporate governance.

“As a financial expert with decades of strategic operational experience in large, complex companies, Tracey’s insights will be helpful as we continue to grow and strengthen our capabilities in the evolving health care landscape,” said Steve Rusckowski, Chairman, CEO and President. “We are pleased to welcome her to our Board.”

Timothy M. Ring, Lead Independent Director, added: “Tracey brings strong leadership, innovation and collaboration skills to our Board. We are fortunate that she has joined our Board.”

Ms. Doi serves as an independent trustee of SunAmerica Series Trust and Season Series Trust, and on the board of City National Bank, a Royal Bank of Canada Company. She served on the Federal Reserve Bank of San Francisco Economic Advisory Council from 2009 to 2016. Ms. Doi is an active board member of the National Asian American Pacific Islander Chamber of Commerce, 50/50 Women on Boards, and the Japanese American National Museum.

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com

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SOURCE Quest Diagnostics

Posted on August 17, 2021 6:48 am
KULR Technology Group Announces Second Quarter 2021 Financial Results and Provides Shareholder Update Letter

SAN DIEGO, Aug. 17, 2021 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a leading developer of next-generation lithium-ion battery safety and thermal management technologies, today announced its financial results for the second quarter ended June 30, 2021 and posted a Shareholder Letter to its website summarizing corporate updates since the beginning of the second quarter of 2021.

KULR’s Q2 revenue increased by over 200% year-over-year as the Company continued to make significant investments in all areas of its business to sustain and expand in 2021 and beyond. The Company raised $6.5 million in equity capital on May 20, 2021, which strengthened the balance sheet and helped facilitate KULR’s uplisting to the NYSE-American exchange on June 07, 2021. In addition, the Company received approximately $3.7 million in Q2 2021 from the exercise of warrants to purchase an aggregate of 3,000,000 shares of common stocks and approximately $1.5 million from the exercise of warrants to purchase a total of 1,200,000 shares of common stock in July 2021. With over $12 million in cash at end of Q2, KULR is in the strongest financial position in its history.

As KULR accelerates its investments in new technology developments in smart battery platform, battery cell screen and testing automation and fast charging battery architecture, it continues to grow sales in its foundational aerospace and defense businesses. KULR’s business model continues to evolve as the Company focuses on near-term commercialization opportunities for its technology in battery transportation and energy storage products. The Company’s goal is to provide total battery safety solutions for more efficient battery systems, increased sustainability, and end-of-life battery management, making KULR a key technology solutions provider in the migration to a global circular economy.

Second Quarter 2021 and Recent Operational Highlights

KULR received three US Department of Transportation (“DoT”) special permits to allow for the safe transportation of recycled, prototype and DDR (damaged, defective, and recalled) lithium-ion batteries respectively. These special permits allow for up to 2.1 kWh (kilowatt-hour) of energy capacity and retains seven times the energy capacity protection compared to its closest competitor.

The Company is developing its smart battery system, which includes both hardware and software platforms to monitor the health of battery cells; integrating software and services with hardware will enable better control over data intelligence. KULR’s long-term vision is to provide a completely integrated hardware and software platform to manage battery safety and thermal stability.

KULR has designed a battery cell screening and testing automation system for its Department of Defense and Aerospace customers to serve their strategic battery reserve initiatives. The Company has sourced critical test and automation equipment to build out a proprietary test-pilot system. KULR anticipates this system to be capable of processing up to 1.2 million cells per year for the 18650 and 21700 cylindrical battery cells. The test-pilot system is expected to be in full operation in the first half of 2022.

The Company believes fast charging is the killer app of battery energy systems. KULR is developing a carbon fiber-based architecture for thicker cathode and advanced anode materials to enable faster-charging and safer battery cells. The Company expects to show preliminary test results on September 21, 2021 at Battery Solutions Day.

In June 2021, Greg Provenzano joined KULR as the VP of Sales and Marketing. Greg joins KULR with over 35 years of leadership and worldwide sales experience in electronic components, design services, and system solutions across a variety of industries most notably at Advanced Energy and Arrow Electronics. At KULR, he will play a crucial role in developing the Company’s sales channel strategy as it pivots into large volume applications and products supporting strategic growth goals.

During the quarter the Company added a new Vice President of Operations in Antonio Martinez. Antonio joins KULR with over 37 years of leadership and worldwide manufacturing experience in electronics manufacturing and operations. He spent most of his career at Pulse Electronics Corporation in the electronics manufacturing services industry and most recently, served as Principal Program Manager of Jabil since 2015.

In June 2021, KULR was approved to uplist to the New York Stock Exchange (“NYSE”) American Exchange. The “KULR” ticker remains unchanged, and the stock commenced trading at the opening of trading on June 7, 2021. Trading on the NYSE provides the Company more visibility to a much broader pool of institutional and retail investors and, in turn, increases liquidity.

During the quarter KULR appointed Lieutenant General Stayce D. Harris to the Board of Directors. General Harris, who also serves as Chairperson of the KULR’s Compensation Committee, is a retired United States Air Force Reserve Lieutenant General that last served as the Inspector General of the Air Force. She is an experienced pilot with over 10,000 flight hours safely transporting passengers and cargo worldwide for United Airlines and was a pilot for nearly 30 years before retiring from the company in 2020. Stayce serves as a Director of The Boeing Company, an independent Director/Trustee of BlackRock Fixed-Income Mutual Funds and is a member of the Board of Directors for Direct Relief.

Financial Results: Second Quarter 2021 vs. Second Quarter 2020

Following the successful fund raising and NYSE uplisting in 2021, the Company is building the foundations for a business expansion plan, including hiring additional engineering staff, senior management, expanded facilities, new and automated test and production equipment, advertising, and marketing expenses, as well as investor relations activities. While this investment impacts short term profitability, KULR believes this will pave the way for longer term growth and improved shareholder value.

Revenues: KULR generated revenues of $0.6 million in the second quarter ended June 30, 2021, an increase of 212% compared with revenues of $0.2 million reported in the same period of 2020. The increase in revenue was mainly due to increased sales of KULR products. These results reflect management’s continuing efforts to develop new and existing customer relationships through a growing pool of referrals and business development leads.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses increased to $2.8 million in the second quarter of 2021 from $0.4 million in the corresponding period last year. The 556% increase in SG&A expenses was due to additional marketing and advertising expenses, consulting fees and non-cash stock-based compensation paid to employees and consultants.

R&D expenses: R&D expenses in the second quarter of 2021 increased by 437% to $0.31 million from $0.06 million in the same period last year, reflecting a combination of headcount and process improvements implemented in the first quarter of 2021.

Operating Loss: Loss from operations was $2.9 million for the second quarter of 2021, compared to $0.3 million for the comparable quarter of 2020. The $2.6 million increase in the operating loss included a $1.0 million increase in non-cash stock-based compensation expense, a $0.7 million increase in advertising and marketing expense, a $0.3 million increase in payroll costs, a $0.2 million increase in professional fees and a $0.2 million increase in research and development projects.

Net Loss: Net loss for the second quarter of 2021 increased to $3.0 million compared with a net loss of $0.4 million for the comparable period in 2020.

Net Loss Per Share: Net loss per share for the second quarter of 2021 was $0.07, as compared to $0.01 for the comparable period in 2020. The comparison was unfavorably impacted by higher selling, general and administrative costs and the deemed dividend associated with the 2021 preferred stock financing, partially offset by the favorable impact of the increase in revenues. The deemed dividend represents a non-cash adjustment to the numerator in the loss per share calculation pursuant to generally accepted accounting principles in the United States of America, but it is not recorded in the Company’s basic financial statements.

Cash Position: On June 30, 2021, the Company reported cash balances of $12.2 million compared with $8.9 million on December 31, 2020. This funding leaves us well positioned to expand operations, support new business, and fund ongoing product developments despite the difficult Covid inspired trading conditions experienced through the latest quarter.

Shareholder Update Call:

KULR will hold a conference call on Tuesday, August 24 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its financial results for the second quarter ended June 30, 2021.

KULR management will host the presentation, followed by a question-and-answer period.
Interested parties may submit questions to the Company prior to the call at [email protected].

Submissions must be received by August 20 at 8:00 PM ET. Questions will be addressed based on the relevance to the Company’s strategic direction and execution, shareholder base and public disclosure rules.

Date: Tuesday, August 24, 2021
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
U.S. dial-in: 877-407-3088
International dial-in: 201-389-0927

Please call the conference telephone number 10 minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact Gateway Investor Relations at 949-574-3860.

The conference call will be broadcast live and available for replay here and via the Investor Relations section of KULR’s website.

A telephonic replay of the conference call will be available after 7:00 p.m. Eastern time on the same day through August 31, 2021.

Toll-free replay number: 877-660-6853
International replay number: 201-612-7415
Replay ID: 13722392

About KULR Technology Group Inc.

KULR Technology Group Inc. (NYSE American: KULR) develops, manufactures and licenses next-generation carbon fiber thermal management technologies for batteries and electronic systems. Leveraging the company’s roots in developing breakthrough cooling solutions for NASA space missions and backed by a strong intellectual property portfolio, KULR enables leading aerospace, electronics, energy storage, 5G infrastructure, and electric vehicle manufacturers to make their products cooler, lighter and safer for the consumer. For more information, please visit www.KULRTechnology.com.

Safe Harbor Statement

This release does not constitute an offer to sell or a solicitation of offers to buy any securities of any entity. This release contains certain forward-looking statements based on our current expectations, forecasts and assumptions that involve risks and uncertainties. Forward-looking statements in this release are based on information available to us as of the date hereof. Our actual results may differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with our business, which include the risk factors disclosed in our Form 10-K filed with the Securities and Exchange Commission on March 19, 2021. Forward-looking statements include statements regarding our expectations, beliefs, intentions, or strategies regarding the future and can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. All forecasts are provided by management in this release are based on information available at this time and management expects that internal projections and expectations may change over time. In addition, the forecasts are entirely on management’s best estimate of our future financial performance given our current contracts, current backlog of opportunities and conversations with new and existing customers about our products and services. We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.

Media Contact:

Derek Newton
Head, Media Relations
Main: (786) 499-8998
[email protected]

Investor Relations:

Tom Colton or Matt Glover
Gateway Investor Relations
Main: (949) 574-3860
[email protected]

Posted on August 17, 2021 6:48 am
Ocean Power Technologies Announces DOE Award Supporting Development of Next Generation Wave Energy Converter Concept

MONROE TOWNSHIP, N.J., Aug. 17, 2021 (GLOBE NEWSWIRE) — Ocean Power Technologies, Inc. (“OPT” or “the Company”) (NYSE American: OPTT), a leader in innovative and cost-effective low-carbon ocean energy solutions, today announced that the U.S. Department of Energy (DOE) selected the Company to further the development of a next-generation wave energy converter.

“Investment by the U.S. government towards the commercialization of clean energy technology is critical to achieving our nation’s net-zero emissions goals,” said Philipp Stratmann, President and Chief Executive Officer of OPT. “This award from the DOE will allow OPT to continue innovative blue tech power and data solution development.”

In the DOE’s recently announced awards for clean energy Small Business Innovation Research (SBIR) projects, OPT will receive up to $197,203 to perform a preliminary conceptual design and feasibility study of a modular and scalable small-scale Mass-on-Spring Wave Energy Converter (MOSWEC) PowerBuoy® for powering autonomous ocean monitoring systems.

OPT holds multiple patents related to MOSWEC technology, which generates power from the relative motion caused by the ocean waves. OPT’s MOSWEC design has a hermetically sealed hull to protect internal components, is about the size of a standard shipping container, and is easily transportable and deployable. In addition, the design is scalable to support a wide range of applications and missions.

About Ocean Power Technologies

Headquartered in Monroe Township, New Jersey, OPT aspires to transform the world through durable, innovative, and cost-effective ocean energy solutions. Its PowerBuoy^® solutions platform provides clean and reliable electric power and real-time data communications for remote offshore and subsea applications in markets such as offshore oil and gas, defense and security, science and research, and communications. To learn more, visit www.oceanpowertechnologies.com.

Forward-Looking Statements

This release may contain forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as “may”, “will”, “aim”, “will likely result”, “believe”, “expect”, “will continue”, “anticipate”, “estimate”, “intend”, “plan”, “contemplate”, “seek to”, “future”, “objective”, “goal”, “project”, “should”, “will pursue” and similar expressions or variations of such expressions. These forward-looking statements reflect the Company’s current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company’s most recent Forms 10-Q and 10-K and subsequent filings with the U.S. Securities and Exchange Commission for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.

Contact Information Investors: 609-730-0400 x401 or [email protected] Media: 609-730-0400 x402 or [email protected]

Posted on August 17, 2021 6:48 am
TCR² Therapeutics Announces Upcoming Medical Meetings Update

CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) — TCR² Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, today announced that their interim update on the Phase 1/2 clinical trial of gavo-cel will be featured in the official Press Programme at the European Society for Medical Oncology (ESMO). Additionally, due to TCR² opting to not present its accepted featured poster presentation on September 8, 2021 at the World Conference on Lung Cancer (WCLC), the Company was notified by the WCLC of their decision to withdraw its abstract titled “Phase 1 Trial of Gavocabtagene Autoleucel (gavo-cel, TC-210) In Refractory Mesothelin-Expressing Solid Tumors.”

The Company will highlight all of its new clinical data from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with refractory mesothelin-expressing solid tumors as part of an oral presentation at the ESMO Congress 2021 on September 17 at 14:20 CEST (8:20am EST). The presentation will include clinical and translational data from at least 17 evaluable patients treated with gavo-cel up to dose level 5 (DL5). In addition to malignant mesothelioma and ovarian cancer, the presentation will include data from a third mesothelin-expressing solid tumor indication, cholangiocarcinoma.

“We look forward to reviewing the full dataset in our oral presentation at ESMO where we can thoroughly discuss the compelling results of gavo-cel in now three different solid tumor indications. We believe this data set, focusing on consistency in tumor regression, disease control and improvement in overall survival, will help determine whether gavo-cel as a monotherapy is the most promising mesothelin-directed therapy in the clinic,” said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR² Therapeutics.

Title: Phase 1 Trial of Gavocabtagene Autoleucel (gavo-cel, TC-210) In Refractory Mesothelin-Expressing Solid Tumors
Presentation: #959O
Speaker: David S. Hong, MD Anderson Cancer Center
Session: Investigational Immunotherapy

About TCR
²
Therapeutics

TCR² Therapeutics Inc. is a clinical-stage cell therapy company developing a pipeline of novel T cell therapies for patients suffering from cancer. TCR²’s proprietary T cell receptor (TCR) Fusion Construct T cells (TRuC^®-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent of human leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while secreting lower levels of cytokines. The Company’s lead TRuC-T cell product candidate targeting solid tumors, gavo-cel, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Company’s lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR², please visit www.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the timing of release of data from the Company’s gavo-cel clinical trials, the therapeutic potential of gavo-cel and the potential of gavo-cel in relation to other clinical-stage mesothelin-directed therapies.

The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR²’s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR²‘s cash resources will be sufficient to fund TCR²‘s foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR²’s ongoing operations; and other risks set forth under the caption “Risk Factors” in TCR²’s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR² believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR² nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contact:

Carl Mauch
Director, Investor Relations and Corporate Communications
TCR² Therapeutics Inc.
(617) 949-5667
[email protected]

Posted on August 17, 2021 6:33 am
Stanley Black & Decker To Acquire Remaining 80 Percent Stake In MTD Holdings For $1.6 Billion, Creating Global Leader In Outdoor Products

– Transaction To Unleash A Runway For Growth, With Strong Brands, Innovation and Channel Opportunities

– Expected To Add $0.50 Per Share To 2022 Earnings, More Than $1.00 By Year Four, Excluding Charges

PR Newswire

NEW BRITAIN, Conn., Aug. 17, 2021 /PRNewswire/ — Stanley Black & Decker (NYSE: SWK) today announced that it has agreed to acquire the remaining 80 percent ownership stake in MTD Holdings Inc. (“MTD”), a privately held global manufacturer of outdoor power equipment, including Cub Cadet® and Troy-Bilt®, for $1.6 billion in cash. Stanley Black & Decker acquired a 20 percent stake in MTD in 2019.

“We have worked directly with MTD over the last 3 years and have been impressed with the quality of the management team, their talented employees and MTD’s relentless dedication to innovation in the outdoor space,” said Stanley Black & Decker’s CEO James M. Loree. “The combination of businesses will create a global leader in the $25 billion and growing outdoor category, with strong brands and growth opportunities that align with two market trends driving our business – the consumer reconnection with the home and garden and electrification. We have clearly identified multiple levers to drive growth and margin expansion and are looking forward to welcoming MTD’s 7,500 employees to our Stanley Black & Decker family.”

MTD’s Chairman, CEO and President Robert T. Moll said, “My grandfather founded MTD nearly 90 years ago, and I’m as proud of our history as I am excited about our future with Stanley Black & Decker. Both companies are proven leaders in our respective industries with iconic brands, world class capabilities and a passion for bringing new and innovative products to our consumers. I know we are partnering with an organization that will continue to deliver on our purpose of inspiring people to care for and enjoy the outdoors.”

With over $2.5 billion of revenue in the last twelve months, MTD designs, manufactures and distributes lawn tractors, zero turn mowers, walk behind mowers, snow blowers, residential robotic mowers, handheld outdoor power equipment and garden tools for both residential and professional consumers under well-known brands like Cub Cadet® and Troy-Bilt®. MTD has state-of-the-art manufacturing facilities in North America and Europe, and a global distribution network.

Together Stanley Black & Decker and MTD have a compelling pathway to introduce new and innovative products for professional and residential outdoor equipment customers. MTD has made significant progress in improving its EBITDA margin from 4.5% in 2018 to high single digits over the last twelve months and there is runway for further EBITDA margin improvement to the mid-teens over the next four years as cost and revenue opportunities are realized.

The Company expects the transaction to result in cumulative annual cost synergies of approximately $100 million by 2025. Our planning assumption for 2022 carries revenue of approximately $2.6 billion and consolidated adjusted EBITDA over $230 million. Using these assumptions, the acquisition is expected to be approximately $0.50 accretive to adjusted earnings per share in 2022, increasing to over $1.00 by 2025. One time charges associated with the acquisition are expected to be $175 – $200 million of integration, restructuring and other deal related costs and approximately $125 – $150 million of non-cash charges such as inventory step-up, which in the aggregate will largely be incurred upon closing and during the first three years of ownership. The total purchase price represents an adjusted LTM EBITDA multiple of approximately 8x.

Donald Allan Jr., President and CFO, commented, “The acquisition of MTD creates a multi-year roadmap for organic revenue, profitability and cashflow growth. We expect to generate significant revenue synergies as we capitalize on the two companies’ collective technology investments, strong brands and global customer relationships. We have significant balance sheet flexibility supported by strong free cash flow generation to fund the MTD acquisition and to consider other capital deployment opportunities. We are excited to begin the next phase of our journey with MTD to realize these benefits, deliver high-teens return on capital, and build an innovative outdoor products leader.”

The acquisition, which is subject to regulatory approvals and customary closing conditions, is expected to close in 2021 and will be funded with a combination of cash on hand and proceeds from debt incurrence, which we expect to include support by new credit facilities.

Stanley Black & Decker, an S&P 500 company, is a leading $14.5 billion global diversified industrial with 56,000 employees in more than 60 countries who make the tools, products and solutions to deliver on its Purpose, For Those Who Make The World. The Company operates the world’s largest tools and storage business; the world’s second largest commercial electronic security company; and is a global industrial leader of highly engineered solutions within its engineered fastening and infrastructure businesses. Learn more at www.stanleyblackanddecker.com.

Inspiring people to care for and enjoy the outdoors, MTD Holdings Inc is known for innovative and award-winning lawn mowers, snow blowers, trimmers, and outdoor power equipment for both residential and commercial markets. The company was founded in 1932 and is headquartered in Valley City, Ohio. The MTD family of brands includes Cub Cadet®, Troy-Bilt®, Robomow®, Rover®, and WOLF-Garten® – all backed by a strong network of MTD support focused on uncompromising quality, service and value through advanced manufacturing. Products designed, manufactured, distributed, and sold by MTD can be found in retail outlets large and small all over the world. For more information, please visit www.mtdproducts.com.

Investor Contacts:

Dennis Lange

Vice President, Investor Relations
[email protected]
(860) 827-3833

Cort Kaufman

Director, Investor Relations
[email protected]
(860) 515-2741

Christina Francis

Director, Investor Relations
[email protected]
(860) 438-3470

Media Contacts:

Shannon Lapierre

Chief Communications Officer
[email protected]
(860) 259-7669

Debora Raymond

Vice President, Public Relations
[email protected]
(203) 640-8054

MTD Holdings Inc. Contacts:

Heidi Ketvertis

Vice President, Marketing
[email protected]
(330) 558-7038

Erica Creech

Manager, Corporate Communications
[email protected]
(330) 558-7285

Cautionary Note Regarding Forward-Looking Statements

Stanley Black & Decker makes forward-looking statements in this press release which represent its expectations or beliefs about future events and financial performance. Forward-looking statements are identifiable by words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward looking statements made in this press release, include, but are not limited to, statements concerning: the consummation of Stanley Black & Decker’s acquisition of the remaining 80 percent stake in MTD; MTD’s business complementing and expanding Stanley Black & Decker’s existing operations; cost and revenue synergies; growth and margin expansion opportunities; anticipated accretion, return on capital and one-time acquisition-related charges; and operational efficiencies.

You are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements are not guarantees of future events and involve known and unknown risks, uncertainties and other factors that may cause actual results and performance to be materially different from any future results or performance expressed or implied by such forward-looking statements, including, but not limited to, the failure to consummate, or a delay in the consummation of, Stanley Black & Decker’s acquisition of the remaining 80 percent stake in MTD for various reasons; failure to successfully integrate MTD and achieve expected cost and revenue synergies; failure to achieve expected growth, margin expansion, accretion or return on capital; or the acquisition-related charges being greater than anticipated.

Forward-looking statements made herein are also subject to risks and uncertainties, described in: Stanley Black & Decker’s 2020 Annual Report on Form 10-K, its subsequently filed Quarterly Reports on Form 10-Q; and other filings Stanley Black & Decker makes with the Securities and Exchange Commission. In addition, actual results could differ materially from those suggested by the forward-looking statements. Stanley Black & Decker makes no commitment to revise or update any forward-looking statements to reflect events or circumstances occurring or existing after the date of any forward-looking statement.

View original content to download multimedia:https://www.prnewswire.com/news-releases/stanley-black–decker-to-acquire-remaining-80-percent-stake-in-mtd-holdings-for-1-6-billion-creating-global-leader-in-outdoor-products-301356361.html

SOURCE Stanley Black & Decker

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